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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  ceritinib
Trade Name:  ZYKADIA
Date Designated:  09/27/2013
Orphan Designation:  Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/26/2017 
Approved Labeled Indication:  Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test
Exclusivity End Date:    05/26/2024 
Exclusivity Protected Indication* :  Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test
Novartis Pharmaceuticals Corp.
One Health Plaza
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  ceritinib
Trade Name:  ZYKADIA
Date Designated:  09/27/2013
Orphan Designation:  Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/29/2014 
Approved Labeled Indication:  ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic nonsmall cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Exclusivity End Date:    04/29/2021 
Exclusivity Protected Indication* :  Treatment of patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Novartis Pharmaceuticals Corp.
One Health Plaza
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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